RecruitingNot ApplicableNCT05794035

Impact of Hypofractionated Radiotherapy Strategy After Surgery of Skin Carcinomas in Older Patients

Impact of Hypofractionated Radiotherapy Strategy After Surgery of Skin Carcinomas in Older Patients IMPACTE-01


Sponsor

Assistance Publique - Hôpitaux de Paris

Enrollment

303 participants

Start Date

Oct 17, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

Non-melanoma skin cancer (NMSC) incidence as well as morbidity rates are high in older patients. Surgery is the standard of care. About 5 to 10% of NMSC present high-risk clinico-pathologic features that can increase risk of local recurrence (LR). Adjuvant radiation therapy (ART) is often discussed regarding the risk of local recurrence. Despite the lack of high level evidence, ART is indicated in patients according to unfavorable prognostic factors. ART benefit is generally questioned in regard to the potential degradation of the patient's quality of life (QoL). Currently there is no prospective trial or recommendations that take into account geriatric patients' evaluation and profiles during the management of NMSC. In addition, there is no data that could help to define the subgroup of elderly patients who will benefit from ART in tumors with unfavorable prognostic factors. In terms of ART, multiple fractionation schedules are available, ranging from standard fractionation (45-60Gy in 5-6 weeks) to the extreme hypofractionation (HF) delivering 16-18Gy in one fraction. In routine practice, HF is mainly preferred in elderly patients for more convenience by reducing the number of transports and increase health related quality of life (HRQoL). However, there is no data on the fragility profiles of these patients, nor validating any HF schedule in terms of efficacy, acute toxicity, cosmetic results, and impact on HRQoL. the main ain objective is to evaluate the comparative efficacy of two modalities of Radiotherapy over surgery alone on local tumor control in older patients with Non Melanoma Skin Cancer (NMSC) In current practice, adjuvant radiotherapy is discussed regarding the risk of local recurrence as determined by the existence (or not) of unfavorable prognostic factors. The proposed study will include R0-high risk of CBC and CEC of the skin in elderly patients. There is no risk regarding the design of the trial as the last will respond to two important unknown questions regarding the utility of RT and its fractionation in this population. Moreover, it is an excellent opportunity to collect prospectively geriatric evaluation and HRQoL data that are lacking in the literature for skin cancers. No constraints are seen neither in the design, nor in the potential recruitments.


Eligibility

Min Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a shorter course of radiation therapy (called hypofractionated radiotherapy) after skin cancer surgery in older patients. The goal is to reduce the number of treatment sessions while still effectively preventing cancer from coming back. **You may be eligible if...** - You are 70 years or older - You have been diagnosed with invasive squamous cell carcinoma (SCC) or basal cell carcinoma (BCC) of the skin, confirmed by tissue analysis - You have at least one factor that increases the chance of the cancer returning (such as close surgical margins, tumor location/size, nerve invasion, or a recurrent tumor) - You have not had prior radiation therapy at the same site - You or your legal representative has provided written consent **You may NOT be eligible if...** - You need radiation to the lymph nodes in the nearby region - You have already had radiation at the area being treated Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERSurgery with additional moderate hypofractionation RT (15 fractions)

After randomization, patients will then be followed-up at 3 months post randomization and at each surveillance visit (M6, M12, M24 and M36). Adjuvant Radiotherapy: -Arm B: Surgery followed by moderate hypofractionation RT (15 fractions): 45Gy in 15 fractions, 3 fractions per week over 5 weeks to the operative bed.

OTHERSurgery alone, without radiation post surgery

Arm A: Surgery alone followed by surveillance

RADIATIONSurgery with extreme hypo fractionation treatment (HF)

After randomization, patients will then be followed-up at 3 months post randomization and at each surveillance visit (M6, M12, M24 and M36). Adjuvant Radiotherapy: -Arm C= Surgery followed by extreme hypofractionation RT (5 fractions, 2 fractions/week): 30Gy in 5 fractions of 6Gy over 5 weeks to the operative bed.


Locations(1)

Henri Mondor

Créteil, France

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NCT05794035


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